The invention relates to a response form containing a means of input that on manual influence is capable of switching an electrical circuit connected to an electronic unit incorporated into the response form for registration of the said influence.
Certain pharmaceutical companies have recently started to use electronic patient journals during trials of pharmaceuticals. These are currently based on different types of hand-held computers that are programmed so that questions and answers can be registered at a particular time. Such systems have great advantages, but they also have disadvantages such as a high unit cost, expensive special programming, a short period of operation, limited areas for text and images, sensitivity to rough treatment and being attractive objects for theft.
The main reason that these systems have achieved only limited success is that they are experienced as expensive and complicated to manage. None of these systems can record when the pharmaceutical has been removed from its package, but can only remind the patient with a sound or light signal at the specified time for tablet withdrawal.
It has been established in several studies that a clearly significant fraction of patients during pharmaceutical trials do not take the pharmaceutical according to the prescription. This contributes to a large uncertainty during the statistical evaluation of the effects and side-effects of pharmaceuticals.
The pharmaceutical industry currently uses various methods to measure the compliance of patientsxe2x80x94their ability to follow the prescription. The most reliable method is to continuously measure the levels of the substance in the blood and urine. In most cases, this in neither practical nor economically possible. The most usual method is to count the number that has been used and to interview the patient. This method is particularly uncertain in that it is based on the assumption that the substance has been taken in the right way at the right time.
The compliance of patients can also be measured by different types of pharmaceutical package that register the time of withdrawal.
The aim of the current invention is to provide a response form or a questionnaire of the type specified in the introduction, that can be produced at low cost and used as a patient journal, and that can be integrated with a pharmaceutical package.
The invention achieves this aim by having the special properties that are specified in the following claim 1.
According to an aspect of the invention, the response form is composed of a disposable material in the form of a sheet, with the electric circuit printed onto one side of it. The means of input can consist of a switch or circuit maker visibly marked on one side of the disposable material and arranged to form an electrical connection across an interrupted loop of the conducting circuit when influenced by local pressing together of the sides of the disposable material that face each other. The means of input can also consist of a circuit breaker visibly marked on pieces of the disposable material and arranged to cause electrical interruption in a loop of the conducting circuit when influenced by at least partial removal of the loop from the disposable material.
A completed example of such a response form including printed questions, conducting circuits and circuit makers/circuit breakers can be mass produced at a low cost in graphical printing and paper sheet handling machines. The electronic unit, which may have the form of a telephone card, can be inserted into the response form and connected to the conducting circuit, for example, when issuing the response form, and it may be possible to recycle the electronic unit when the form is returned, by inserting it into a new response form.
If the response form is integrated with a pharmaceutical package that registers withdrawals, for example of a likewise disposable material in the form of a sheet, then both journal notes and compliance data can be stored in an electronic unit common to the form and the package.